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Panels › Clinical Chemistry › Product code JKA · Class 2

Tubes, Vials, Systems, Serum Separators, Blood Collection

Regulation 862.1675

8510(k)s in 12 months (239 all time)
14recalls in 12 months (171 all time)
156recalls that name a 510(k)
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Top companies in JKA

DateFirm and productCodeLinked 510(k)
Sep 12, 2014Fresenius Medical Care Holdings, Inc.
BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 Part Number: FMC 87-7841-7 Single use tube used to collect, separate, transport or process blood specimens for laboratory de
Terminated
JKAK921806
Sep 12, 2014Fresenius Medical Care Holdings, Inc.
BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory
Terminated
JKAK960250
Mar 12, 2014Smiths Medical ASD, Inc.
G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, Needle-Pro Device and 23G x 1 needle Arterial Blood Sampling Line Draw Syringes are sterile,
Terminated
JKAK952516
Mar 12, 2014Smiths Medical ASD, Inc.
G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro devices and (2) Needle-Pro Devices with 22G x 1needles Arterial Blood Sampling Line
Terminated
JKAK952516
Mar 12, 2014Smiths Medical ASD, Inc.
G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, syringe tip cap, and 5 mL Luer lock syringe Arterial Blood Sampling Line Draw Syringes are s
Terminated
JKAK952516
Mar 12, 2014Smiths Medical ASD, Inc.
G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device and 1 mL Line Draw Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro
Terminated
JKAK952516
Mar 12, 2014Smiths Medical ASD, Inc.
G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Japan only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use
Terminated
JKAK952516
Mar 12, 2014Smiths Medical ASD, Inc.
4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use
Terminated
JKAK952516
Mar 12, 2014Smiths Medical ASD, Inc.
4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use
Terminated
JKAK952516
Mar 12, 2014Smiths Medical ASD, Inc.
4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnost
Terminated
JKAK952516
Mar 12, 2014Smiths Medical ASD, Inc.
4043W-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, syringe tip cap and 6 mL Luer slip syringe Arterial Blood Sampling Line Draw Syringes are
Terminated
JKAK952516
Mar 12, 2014Smiths Medical ASD, Inc.
4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device and ice bag Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in
Terminated
JKAK952516
Mar 12, 2014Smiths Medical ASD, Inc.
4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagno
Terminated
JKAK952516
Mar 12, 2014Smiths Medical ASD, Inc.
4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagno
Terminated
JKAK952516
Mar 12, 2014Smiths Medical ASD, Inc.
4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, 22g x 1 needle, and Point-Lok needle safety device Arterial Blood Sampling Line D
Terminated
JKAK952516
Oct 18, 2013Perkin Elmer Health Sciences, Inc.
Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood
Terminated
JKAK121864
Aug 7, 2013Becton Dickinson & Company
BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets,
Terminated
JKANone listed
Mar 6, 2013Becton Dickinson & Company
BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA. Used in hospitals, outpa
Terminated
JKAK945952
Nov 12, 2012Becton Dickinson & Company
BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL
Terminated
JKAK013971
Feb 24, 2012Capitol Vial Inc
Oral-Eze (R) Oral Fluid Collection System, manufactured by Capitol Vial, Inc., Auburn, AL 36832 Product Usage: IVD for drugs of abuse
Terminated
JKAK984361
Feb 22, 2012Greiner Bio-One North America, Inc.
LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC 28110. Venous blood collection tubes.
Terminated
JKAK960857
Jan 11, 2012Heritage Labs International LLC
Heritage Labs Blood/Urine Collection Kit, Product A1100, packed in bags in bulk, 25 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood
Terminated
JKAK883787
Jan 11, 2012Heritage Labs International LLC
Biometric Combo Test Kit, Product K8500, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and
Terminated
JKAK993787
Jan 11, 2012Heritage Labs International LLC
AGLH - Lung Health Study, Specimen Collection & Return Kit, Phlebotomy & Urine Kit, Product A2351, 10 kits/shipping carton, each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 507
Terminated
JKAK993787
Jan 11, 2012Heritage Labs International LLC
Bravo Wellness Kit, Product A1778, each kit packed in a bag or envelope. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies, a
Terminated
JKAK993787
Nov 25, 2011Immunetech Inc
ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8024, Provider Pack: 5 test, Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the non-sterile al
Terminated
JKAK021698
K061979
Nov 25, 2011Immunetech Inc
ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8021, Screening Pack: 100 test (with lancet & capillary), Product is manufactured distributed by ImmuneTech, Inc., Foster City,
Terminated
JKAK021698
K061979
Nov 25, 2011Immunetech Inc
ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8015, Screening Pack: 50 test (with lancet), Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the
Terminated
JKAK021698
K061979
Nov 25, 2011Immunetech Inc
ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8014, Provider Pack: 10 test (without lancet), Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the
Terminated
JKAK021698
K061979
Nov 25, 2011Immunetech Inc
ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8013, Provider Pack: 10 test (with lancet), Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the
Terminated
JKAK021698
K061979
Nov 25, 2011Immunetech Inc
ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8001; Individually Packaged Kit, Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the non-steri
Terminated
JKAK021698
K061979
Nov 14, 2011Greiner Bio-One North America, Inc.
Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209.
Terminated
JKAK971236
Nov 8, 2011Becton Dickinson & Company
BD Microtainer MAP Microtube for Automated Process with K2EDTA. For the collection, transport, and automated processing of skin punctures samples from infants, children, geriatric, oncology, and cr
Terminated
JKAK093972
Mar 7, 2011Covidien LP
MONOJECT Blood Collection Tubes containing heparin 10x64 Sodium Heparin Item code 8881320256
Terminated
JKAK883320
Mar 7, 2011Covidien LP
MONOJECT Blood Collection Tubes containing heparin 10x50 Sodium Heparin Item code 8881320157
Terminated
JKAK883320
Mar 7, 2011Covidien LP
MONOJECT Blood Collection Tubes containing heparin 13x100 sodium heparin trace element Item Code 8881307014
Terminated
JKAK883320
Dec 16, 2010Greiner Bio-One North America, Inc.
Vacuette 2 ml Lithium Heparin, Collection Tube, Manufactured by: Greiner-Bio One North America, Inc., 4238 Capital Drive, Monroe, NC. Venous blood collection tubes.
Terminated
JKAK960857
Sep 7, 2010Whatman, Inc.
Whatman Body Fluid Collection Paper- 903 California Newborn Screening Card Ref 110534 903 Card are intended for use by healthcare professionals in the collection and in-vitro storage of neonate human
Terminated
JKAK932661
Mar 5, 2010Whatman, Inc.
Whatman Body Fluid Collection Paper 903, Ref: 10534790, for IVD use. Whatman Inc., Florham Park, NJ. The device is used by healthcare professionals in the collection and in-vitro storage of neonate b
Terminated
JKAK932661
Sep 30, 2009Whatman, Inc.
Whatman Body Fluid Collection Paper 903 The device is used by healthcare professionals in the collection and in-vitro storage of neonate blood.
Terminated
JKAK932661
Nov 7, 2008Greiner Bio-One North America, Inc.
VACUETTE, 2 ml Lithium Heparin Venous Blood Collection Tubes. Reference #454237, 13x75 green cap-white ring, 24 racks of 50 pcs (1200 pcs in total, non ridged, Sterile). Manufactured by: Greiner bi
Terminated
JKAK960857
Aug 23, 2008StatSpin, Inc., dba Iris Sample Processing
StatSampler 200 uL, Li Heparin (micro blood collector) Ref: SS2H Packed in Catalog Numbers: SS2H (I vial), SS2H-06 (6 kits/case), CH2C-I0 (I0 vials/kit) Intended for collection and processing of cap
Terminated
JKAK896206
Jul 18, 2008Celsus Laboratories Inc
Celsus Laboratories Heparin Lithium Lyophilized; Lithium Heparin for use in blood collection tube devices and in vitro diagnostic devices.
Terminated
JKANone listed
Jan 23, 2008Becton Dickinson & Company
BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder; Catalog Number: 368656; 23 g X12 " PBBCS w/PAH (Preattached), BD Diagnostics, Franklin Lakes, NJ
Terminated
JKAK011984
Jan 23, 2008Becton Dickinson & Company
BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder;Catalog Number : 367352: 21G x 3/4" x 12"; 0.8 x 19mm x 305mm, Wingset PBBCS, BD Diagnostics, Franklin Lakes, NJ
Terminated
JKAK011984
May 10, 2007Becton Dickinson & Company
BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder. Color green. 21 Gauge. Translucent, integrated protective shield that provides one-handed activation immediately after use, 0.7
Terminated
JKAK980414
Dec 6, 2006Becton Dickinson & Company
BD Vacutainer Luer-Lok Access Device Holder with Pre-Attached Multiple Sample Adapter Sterile, Do Not Reuse, Keep away from heat, Rx only Ref # 364902 200 (4X50) BD Franklin Lakes, NJ 07417
Terminated
JKAK991088
Sep 9, 2006Becton Dickinson & Company
BD Vacutainer Luer Adapter; Catalog #367290 and #367300.
Terminated
JKAK991088
Aug 29, 2006Radiometer America Inc
SafePICO Samplers, self-filling arterial blood samplers. The syringe blood samplers are individually packed in plastic pouches and distributed in cartons. Each carton contains ten (10) boxes and eac
Terminated
JKAK043143
Oct 22, 2005Greiner VACUETTE North America
Serum Blood Collection Tubes
Terminated
JKAK960858

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